Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
MILRINONE (MILRINONE LACTATE)
STRIDES PHARMA CANADA INC
C01CE02
MILRINONE
1MG
SOLUTION
MILRINONE (MILRINONE LACTATE) 1MG
INTRAVENOUS
100
Prescription
CARDIOTONIC AGENTS
Active ingredient group (AIG) number: 0131285001; AHFS:
APPROVED
2020-08-12
PRODUCT MONOGRAPH PR MILRINONE LACTATE INJECTION (milrinone lactate injection) SOLUTION FOR INTRAVENOUS USE 1 mg/mL milrinone (as milrinone lactate) 10 ML AND 20 ML VIALS INOTROPE / VASODILATOR Strides Pharma Canada Inc. Date of Revision: 1565, Boul. Lionel-Boulet August 10, 2020 Varennes, Quebec Canada, J3X 1P7 Submission Control No.: 241158 - 1 - PRODUCT MONOGRAPH Pr Milrinone Lactate Injection (milrinone lactate injection) 1 mg/mL milrinone (as milrinone lactate) 10 mL and 20 mL vials THERAPEUTIC CLASSIFICATION Inotrope / Vasodilator ACTION AND CLINICAL PHARMACOLOGY Milrinone lactate injection is a positive inotrope and vasodilator, with little chronotropic activity, different in structure and mode of action from either the digitalis glycosides or catecholamines. Milrinone, at relevant inotropic and vasorelaxant concentrations, is a selective inhibitor of peak III cAMP phosphodiesterase isozyme in cardiac and vascular muscle. This inhibitory action is consistent with cAMP mediated increases in intracellular ionized calcium and contractile force in cardiac muscle, as well as with cAMP dependent contractile protein phosphorylation and relaxation in vascular muscle. Additional experimental evidence also indicates that it is not a beta-adrenergic agonist, nor does it inhibit sodium-potassium adenosine triphosphatase activity as do the digitalis glycosides. Clinical studies in patients with congestive heart failure have shown that milrinone lactate injection produces dose and plasma level-related increase in left ventricular dP/dt, increase in forearm blood flow indicating a direct arterial vasodilator activity of the drug, and improves diastolic function as evidenced by improvement in left ventricular diastolic relaxation. Studies in normal subjects have shown that milrinone lactate injection produces increases in the slope of the left ventricular pressure-dimension relationship, indicating a direct inotropic effect of - 2 - the drug. Both the inotropic and vasodilatory effects have been observed over the therapeu Belgenin tamamını okuyun